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. 2020 Jan 21;111(2):528–535. doi: 10.1111/cas.14252

Table 1.

Summary of exposure in Japanese patients for the exposure‐response safety analysis

Summary exposure, µg/mL Geometric mean (CV%) % Difference Median (P05, P95)
240 mg Q2W 3 mg/kg Q2W 240 mg Q2W 3 mg/kg Q2W
Cavgd28 44.6 (21.4) 32.5 (20.6) 37.2 44.8 (31.6, 61.7) 32.8 (21.9, 45.2)
Cmind28 38.4 (27.7) 27.9 (25.8) 37.6 38.9 (23.5, 59.5) 29.3 (16.5, 41.3)
Cmax1 76.1 (21.0) 55.3 (18.3) 37.6 75.4 (54.6, 108.0) 55.0 (40.7, 73.4)

Cavgd28, nivolumab concentration over the first 28 d; Cmax1, peak concentration after the first dose; Cmind28, trough concentration at day 28; CV, coefficient of variation; P05, fifth percentile; P95, 95th percentile; Q2W, every 2 wk.